Phase 4 Study of Sto M Tab. in Acute or Chronic Gastritis
A Randomized, Double-blinded, Active Controlled, Non-Inferiority, Multicenter, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Sto M Tab. in Patients With Acute or Chronic Gastritis
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Fase 4
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Male or female adults aged 19 to 75 years at the time of screening.
- Participants diagnosed with acute or chronic gastritis by upper gastrointestinal endoscopy performed within 7 days prior to randomization (Visit 2), with at least one gastric erosion confirmed. Erosions of the esophagus and duodenum are excluded.
- Female participants of childbearing potential or male participants who agree to maintain sexual abstinence or use appropriate contraceptive methods during the study period and for 2 weeks after the last administration of the investigational product. Periodic abstinence, such as calendar, ovulation, symptothermal, or post-ovulation methods, is not considered an acceptable contraceptive method.
- Participants who voluntarily provide written informed consent to participate in this clinical trial.
Exclusion Criteria:
- Participants with any of the following lesions confirmed or accompanied by upper gastrointestinal endoscopy at screening (Visit 1): active or healing peptic ulcer; reflux esophagitis; Barrett's esophagus greater than 3 cm; gastroesophageal varices; esophageal stricture; or other clinically relevant lesions. Participants with ulcer scars may be enrolled.
- Participants who have a history of gastric acid secretion-inhibiting surgery or gastric or esophageal surgery at screening (Visit 1).
- Participants who have been diagnosed with or have a history of Zollinger-Ellison syndrome at screening (Visit 1).
- Participants with inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or intestinal Behcet's disease; primary esophageal motility disorder; or pancreatitis at screening (Visit 1).
- Participants with a history of malignancy within 5 years prior to screening (Visit 1). However, participants who have been completely treated and have had no recurrence for at least 5 years may be enrolled at the investigator's discretion. Participants with gastrointestinal malignancy are excluded regardless of the time since diagnosis. Participants with basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, or carcinoma in situ of other sites may be enrolled at the investigator's discretion if they have been completely treated and have had no recurrence for at least 3 years.
- Participants with current or prior thrombotic disease at screening (Visit 1), such as cerebral thrombosis, myocardial infarction, thrombophlebitis, or venous thrombosis.
- Participants diagnosed with disseminated intravascular coagulation at screening (Visit 1).
- Participants with concomitant hepatic, renal, cardiac, pulmonary, hematologic, or other diseases that, in the investigator's judgment, may affect the efficacy or safety evaluations.
- Participants with current or prior lipid metabolism disorders at screening (Visit 1), such as hyperlipidemia or diabetic hyperlipidemia, or participants who require cautious administration of lipid nutritional products. However, participants whose condition is adequately controlled with medication may be enrolled at the investigator's discretion.
- Participants with hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Participants with a history of hypersensitivity to soybean, peanut, or soybean oil.
- Participants with a history of hypersensitivity to any component of the investigational products, such as tartrazine.
- Participants with clinically significant psychiatric disease at screening (Visit 1).
- Participants who meet any other exclusion criteria related to prior or concomitant medications specified in the protocol.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
Experimental: Sto M Tab. Group
|
Sto M Tab., oral, three times daiy, 2 weeks
|
|
Comparador Ativo: Stillen Tab. Group
|
Stillen Tab., oral, three times daily, 2 weeks
|
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Effective Rate of Gastric Mucosal Erosion Assessed by an Independent Reviewer
Prazo: Baseline and Week 2
|
Proportion of participants whose erosion score improved by at least 50% from baseline to Week 2, as assessed by upper gastrointestinal endoscopy and evaluated by an independent reviewer.
|
Baseline and Week 2
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Effective Rate of Gastric Mucosal Erosion Assessed by the Investigator
Prazo: Baseline and Week 2
|
Proportion of participants whose erosion score improved by at least 50% from baseline to Week 2, as assessed by upper gastrointestinal endoscopy.
|
Baseline and Week 2
|
|
Complete Cure Rate of Gastric Mucosal Erosion Assessed by the Investigator
Prazo: Week 2
|
Proportion of participants with complete resolution of gastric mucosal erosion at Week 2, as assessed by upper gastrointestinal endoscopy.
|
Week 2
|
|
Complete Cure Rate of Gastric Mucosal Edema Assessed by the Investigator
Prazo: Week 2
|
Proportion of participants with complete resolution of gastric mucosal edema at Week 2, as assessed by upper gastrointestinal endoscopy.
|
Week 2
|
|
Effective Rate of Gastric Mucosal Redness Assessed by the Investigator
Prazo: Baseline and Week 2
|
Proportion of participants whose redness score improved by at least 50% from baseline to Week 2, as assessed by upper gastrointestinal endoscopy.
|
Baseline and Week 2
|
|
Effective Rate of Gastric Mucosal Hemorrhage Assessed by the Investigator
Prazo: Baseline and Week 2
|
Proportion of participants whose hemorrhage score improved by at least 50% from baseline to Week 2, as assessed by upper gastrointestinal endoscopy.
|
Baseline and Week 2
|
|
Improvement Rate of Subjective Symptom Score Assessed by the Investigator
Prazo: Baseline and Week 2
|
Proportion of participants whose total subjective symptom score improved by at least 50% from baseline to Week 2, as assessed by a self-reported questionnaire.
|
Baseline and Week 2
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- MTS-STO-401
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